When our values align, there's no limit to what we can achieve.
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.
Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.
Key Accountabilities
Ensuring regulatory, ICH-GCP and protocol compliance.
Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates/escalates significant issues to the project team and develops action plans.
Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company Standard Operating Procedures (SOPs)/processes
Per the Clinical Monitoring Plan (CMP) or SMP: Ability to conduct monitoring activities using different methods, (e.g., both on site and remote) where allowed by country regulations
Conducts source document review and verification of appropriate site source documents and medical records
Verifies required clinical data entered in the Case Report Form (CRF) is accurate and complete
Manages reporting of protocol deviations and appropriate follow up
Documents activities via follow up letters, monitoring reports, communication logs, and other required project documents as per SOPs and CMP and SMP
Conducts follow up for escalated adverse event monitoring (AEM) report queries
Collaborates with primary Site Manager who will act as the primary liaison with site personnel
The Individual
A minimum of 1 year experience as a clinical monitor with demonstrated experience of monitoring (virtual or onsite)
Bachelor’s degree or Registered Nurse (RN) in a related field or equivalent combination of education, training, and experience
Experience of utilizing systems like Siebel Clinical Trial Management System (CTMS), electronic Trial Master File (eTMF), electronic Investigator Site File (eISF) (Florence) OR can demonstrate skill sets that show they have agility to work with new systems to support monitoring practice
Proficiency in local language is required
English proficiency is required
Ability to manage required travel of on a regular basis
Skills
Networking and relationship building skills
Ability to communicate effectively and appropriately with internal and external stakeholders
Ability to adapt to changing technologies and processes
Effectively overcoming barriers encountered during the implementation of new processes and systems
Excellent communication (verbal and written), presentation, and interpersonal skills relating to colleagues and associates, both inside and outside of the organization
Identifies and builds effective relationships with investigator site staff and other stakeholders
Must demonstrate good computer skills and be able to embrace new technologies
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